U.S. patent number 10,172,607 [Application Number 15/203,938] was granted by the patent office on 2019-01-08 for load-sharing rip-stop double row repairs.
This patent grant is currently assigned to Arthrex, Inc.. The grantee listed for this patent is Arthrex, Inc.. Invention is credited to Stephen S. Burkhart.
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United States Patent |
10,172,607 |
Burkhart |
January 8, 2019 |
Load-sharing rip-stop double row repairs
Abstract
A load sharing rip-stop construct and technique for soft tissue
repair, particularly rotator cuff repair. A suture tape is inserted
through the soft tissue (rotator cuff) at a first location. At
least one suture anchor is inserted into bone, adjacent the soft
tissue, the anchor being loaded with at least one length of an
suture with two ends. The ends of the suture are passed through the
soft tissue at a second location which is medial to the first
location, and secured in bone at the second location with an
anchor. The suture tape is then passed over the soft tissue and
secured into the bone at a third location which is lateral to the
first and second locations. The suture tape acts as a "rip-stop,"
not only providing resistance to tissue cutout for the suture, but
also enhancing load distribution.
Inventors: |
Burkhart; Stephen S. (Boerne,
TX) |
Applicant: |
Name |
City |
State |
Country |
Type |
Arthrex, Inc. |
Naples |
FL |
US |
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Assignee: |
Arthrex, Inc. (Naples,
FL)
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Family
ID: |
49513150 |
Appl.
No.: |
15/203,938 |
Filed: |
July 7, 2016 |
Prior Publication Data
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Document
Identifier |
Publication Date |
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US 20160310131 A1 |
Oct 27, 2016 |
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Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
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13872711 |
Apr 29, 2013 |
9526489 |
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61641369 |
May 2, 2012 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B
17/06166 (20130101); A61B 17/0401 (20130101); A61B
90/92 (20160201); A61B 2017/0414 (20130101); A61B
2017/044 (20130101) |
Current International
Class: |
A61B
17/04 (20060101); A61B 17/06 (20060101); A61B
90/92 (20160101) |
References Cited
[Referenced By]
U.S. Patent Documents
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6716234 |
April 2004 |
Grafton et al. |
7892256 |
February 2011 |
Grafton et al. |
8012174 |
September 2011 |
ElAttrache et al. |
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Other References
M Baleani et al., "Comparative study of different tendon grasping
techniques for arthroscopic repair of the rotator cuff," Clinical
Biomechanics 21, pp. 799-803 (2006). cited by applicant .
C. B. Ma et al., "Biomechanical Evaluation of Arthroscopic Rotator
Cuff Repairs: Double-Row Compared with Single-Row Fixation," The
Journal of Bone and Joint Surgery, vol. 88-A, No. 2, Feb. 2006, pp.
403-410. cited by applicant.
|
Primary Examiner: McEvoy; Thomas
Attorney, Agent or Firm: Blank Rome LLP
Parent Case Text
CROSS-REFERENCE TO RELATED APPLICATIONS
This is a divisional of application Ser. No. 13/872,711, filed Apr.
29, 2013, which claims the benefit of U.S. Provisional Application
No. 61/641,369, filed May 2, 2012, the disclosure of which is
incorporated by reference in its entirety herein.
Claims
What is claimed is:
1. A method of attaching soft tissue to bone, comprising the steps
of: passing at least one suture tape with two limbs through soft
tissue at two different locations; providing a lateral row
constructed with two suture-loaded anchors, each of the
suture-loaded anchors comprising four suture ends attached thereto,
each of the two suture-loaded anchors being secured into bone;
passing two suture ends from each of the two suture-loaded anchors
through the soft tissue medially to the two different locations of
the suture tape; providing a medial row constructed with two
knotless fixation devices; capturing each limb of the at least one
suture tape with a separate knotless fixation device of the medial
row; and subsequently, tying at least two static knots with the
four suture ends from the suture-loaded anchors.
2. The method of claim 1, further comprising the steps of:
providing two suture tape limbs of the at least one suture tape
through soft tissue at two or more different locations; providing a
lateral row constructed with one or more suture-loaded anchors,
each of the suture-loaded anchors comprising four suture ends
attached thereto, each of the two suture-loaded anchors being
secured into bone; passing two suture ends from each of the two
suture-loaded anchors through the soft tissue medially to the
different locations of the suture tape; providing a medial row
constructed with one or more knotless fixation devices; capturing
both suture tape limbs of the at least one suture tape with a
separate knotless fixation device of the lateral row so that the
limbs of the suture tapes encircle each of the two suture-loaded
anchors; and subsequently, tying two static knots with the four
suture ends from the suture-loaded anchors.
3. The method of claim 2 wherein the bone is a greater tuberosity
bone bed.
4. The method of claim 1, wherein at least one of the knotless
fixation devices is a swivel anchor with an anchor body and an
anchor tip rotatably attached to the anchor body, wherein the
anchor body is configured to be inserted over the anchor tip for
securing the anchor body and the limb of the at least one suture
tape into bone.
5. The method of claim 1, wherein the knotless fixation devices are
push-in type anchors, screw-in anchors or swivel anchors.
6. The method of claim 1, wherein the soft tissue is a rotator cuff
tissue.
Description
FIELD OF THE INVENTION
The present invention relates to arthroscopic surgery and, more
specifically, to improved methods of attaching tissue to bone, such
as rotator cuff repair.
BACKGROUND OF THE INVENTION
Reattachment techniques of soft tissue to bone employing knotless
fixation devices are known in the art, particularly for the
formation of single and double row constructs in arthroscopic
rotator cuff repairs. For example, the SpeedFix.TM. and
SpeedBridge.TM. techniques, both developed by Arthrex, Inc., use a
threaded swivel anchor, such as Arthrex SwiveLock.RTM. C anchor
(disclosed and described in U.S. Pat. No. 8,012,174) combined with
FiberTape.RTM. (disclosed in U.S. Pat. No. 7,892,256) to create a
quick and secure SpeedFix.TM. construct (a knotless single row
repair) or a SpeedBridge.TM. construct (a knotless double row
repair) with no knots and very few suture passing steps.
In the SpeedBridge.TM. technique, a swivel anchor (preferably an
Arthrex 4.75 mm SwiveLock.RTM. C anchor) loaded with one strand of
FiberTape.RTM. is inserted into a medial bone socket. A
FiberLink.TM. and Scorpion.TM. shuttle both FiberTape.RTM. tails
through the rotator cuff simultaneously. Next, one FiberTape.RTM.
tail from each medial anchor is retrieved and loaded through
another SwiveLock.RTM. C eyelet. The loaded eyelet is inserted into
a prepared lateral bone socket until the anchor body contacts bone,
and the tension is adjusted if necessary. The SwiveLock.RTM. C
driver is rotated in a clockwise direction to complete the
insertion. Using an open ended FiberWire.RTM. cutter, the
FiberTape.RTM. tails are cut to complete the technique.
The above-described SpeedFix.TM. and SpeedBridge.TM. suture bridge
techniques restore the anatomic footprint and are particularly
suitable for rotator cuff tears which usually occur at the
tendon-bone insertion. However, at times, a tear can occur more
medially or be accompanied by lateral tendon loss, precluding the
ability to perform a double row repair. "Rip-stop" suture
configurations have been shown to improve load to failure compared
with simple or mattress stitch patterns. C. B. Ma et al.,
"Biomechanical evaluation of arthroscopic rotator cuff stitches," J
Bone Joint Surg Am, Vol. 86, pp. 1211-1216 (2004). As described in
the Ma publication, a rip-stop suture may be placed as an isolated
suture or with the use of a double- or triple-loaded anchor. In the
case of an anchor, the first set of anchor sutures are used to
create a mattress stitch and the remaining sutures are passed
medial to lateral in a simple pattern. A rip-stop suture with a
double-loaded anchor has a load to failure equivalent to a modified
Mason-Allen stitch. In a follow-up study, it was reported that a
triple-. loaded anchor with a horizontal rip-stop stitch and two
simple stitches demonstrate even less elongation with cyclic
loading (i.e., maintained loop security) and a higher ultimate load
to failure compared to the rip-stop configuration with a
double-loaded anchor. M. Baleani et al., "Comparative study of
different tendon grasping techniques for arthroscopic repair of the
rotator cuff," Clin Biomech (Bristol, Avon), Vol. 21, pp. 799-803
(October 2006). Notably, the highest load to failure is achieved
with a classic double-row repair.
Accordingly, a new surgical technique for double row constructs
with a reinforced medial row (especially for rotator cuff repairs
with lateral tendon loss), using a "rip-stop" suture pattern, is
needed.
SUMMARY OF THE INVENTION
The present invention provides methods and constructs for
reinforced double row rotator cuff repairs using a knotless
load-sharing rip-stop suture in the form of a high strength suture
tape. The methods of the present invention provide enhanced
management of poor soft tissue and bone quality in arthroscopic
repairs (for example, arthroscopic rotator cuff repairs).
A method of soft tissue repair according to the present invention
comprises inter alia the steps of: (i) inserting a suture or a
suture tape through soft tissue at a first location so that the
suture or suture tape extends about parallel to a musculotendinous
junction; (ii) inserting one or more suture anchors into bone and
adjacent the soft tissue, the one or more suture anchors comprising
at least one flexible strand with two ends; (iii) passing at least
one end of the flexible strand through the soft tissue at a second
location which is medial to the first location of the suture or
suture tape; and (iv) passing at least one end of the suture or
suture tape over the soft tissue and securing the at least one end
into the bone at a third location which is lateral to the first and
second locations.
A method of soft tissue repair according to the present invention
comprises inter alia the steps of: (i) inserting a suture or a
suture tape through soft tissue at two different first locations so
that the suture or suture tape extends about parallel to a
musculotendinous junction; (ii) inserting at least one anchor (for
example, first and second anchors) into bone and adjacent the soft
tissue, at two different second locations, each of the first and
second anchors comprising two flexible strands and four ends; (iii)
passing two of the four ends of the flexible strands of each of the
first and second anchors through the soft tissue at two different
third locations which are medial to the two different first
locations of the suture tape; and (iv) passing each limb of the
suture or suture tape over the soft tissue and securing each limb
of the suture or suture tape into the bone at two different fourth
locations which are lateral to the first, second and third
locations.
The technique of the present invention is particularly useful for
rotator cuff repair, and addresses medial tendon tears or tears
with lateral tendon loss which may be precluded by standard
techniques. As noted above, rip-stop suture configurations have
been shown to improve load to failure compared with simple or
mattress stitch patterns and may be particularly valuable in these
settings. The constructs of the present invention provide a
rip-stop rotator cuff repair that combines the advantages of a
rip-stop suture (by providing resistance to tissue cutout) and a
double row of load-sharing suture anchors (minimizing the load per
anchor and therefore the load per suture within each anchor).
Unlike the prior art techniques in which the mattress stitch and
simple stitch are based off the same anchor, in the techniques
described below, the rip-stop suture is independently secured so
that it not only provides resistance to tissue cutout for the
simple sutures but also enhances load distribution.
These and other features and advantages of the present invention
will become apparent from the following description of the
invention that is provided in connection with the accompanying
drawings and illustrated embodiments of the invention.
BRIEF DESCRIPTION OF THE DRAWINGS
FIGS. 1A-1F illustrate schematic views of an anchor-based rip-stop
rotator cuff repair for a rotator cuff tear with lateral tendon
loss (left shoulder, lateral-to-medial view);and
FIGS. 2A-2F illustrate schematic views of a dual rip-stop rotator
cuff repair.
DETAILED DESCRIPTION OF THE INVENTION
The present invention provides methods of forming knotless single
and multiple row constructs with a high strength rip-stop suture,
such as FiberTape.RTM..
Steps of an exemplary rotator cuff repair with load-sharing
rip-stop suture tape in accordance with the present invention
includes the following steps:
1. A suture tape rip-stop is placed as a free inverted mattress
stitch in the rotator cuff about 3 mm lateral to the
musculotendinous junction; 2. Medial anchors are placed in the
greater tuberosity; 3. Sutures from the anchors are placed as
simple stitches that pass medial to the rip-stop suture; 4. The
suture tape rip-stop is retrieved to encircle the rotator cuff
sutures; a. The anterior limb of the rip-stop is retrieved anterior
to the rotator cuff suture limbs; b. The posterior limb of the
rip-stop is retrieved posterior to the rotator cuff suture limbs;
5. The anterior and posterior limbs of the suture tape are secured
to lateral anchor(s); and
6. The rotator cuff sutures are tied, which pass medial to the
rip-stop.
Although the specific embodiments detailed below will be described
with reference to specific repairs using a suture tape such as
FiberTape.RTM. suture and knotless fixation devices such as
SwiveLock.RTM. anchors, the invention is not limited by this
exemplary-embodiment. Accordingly, the present invention
contemplates tissue repairs wherein flexible strands with different
width and/or diameters (for example, tapes and/or braids and/or
suture tapes or combinations of tapes and sutures) are employed and
with any fixation devices such as anchors, i.e., not limited to
knotless fixation devices such as SwiveLock.RTM. anchors. Further,
although the embodiments below will be described with reference to
particular rotator cuff repairs, the invention contemplates repairs
of any soft tissue, ligament, tendon, etc. For example, the
invention contemplates ant repair/reinforcement of soft tissue,
such as rotator cuff repair, Achilles tendon repair, patellar
tendon repair, ACL/PCL reconstruction, hip and shoulder
reconstruction procedures, among many others. Although single and
double-row repairs are detailed below (with one or two exemplary
FiberTape.RTM. sutures passed through soft tissue), the invention
also contemplates repairs with any numbers of multiple rows and/or
with any number of flexible strands (i.e., with multiple suture
tapes and/or wide sutures) as required by the specific and extent
of each repair.
The load-sharing rip-stop double row construct (for tissue repairs
such as rotator cuff repair) of the present invention, described in
more detail below, combines the advantages of a wide rip-stop
suture tape and a double-row repair (FIGS. 1 and 2). The technique
is particularly useful for cases involving medial tears in which
there is limited medial tendon that precludes a standard double-row
repair. As detailed below, one or two FiberTape.RTM. rip-stop
sutures are secured to two BioComposite SwiveLock.RTM. anchors
laterally in a modified SpeedFix.TM. repair. The FiberTape.RTM.
rip-stop provides resistance to tissue cut out for simple sutures
that are passed from a medial row of two BioComposite
Corkscrew.RTM. FT anchors.
A rip-stop suture is an effective method of avoiding cinching while
improving resistance to suture cutout. An anterior-to-posterior
mattress stitch formed of wider suture such as suture tape (placed
independently or originating from an anchor) can be placed through
the rotator cuff and tied on itself. Subsequently, simple sutures
from an anchor are passed medial to the rip-stop suture, which
distributes the medial-to-lateral tensile forces and effectively
decreases the chance of suture cutout. Such a rip-stop suture may
be placed as an isolated suture or with the use of a double- or
triple-loaded anchor (or multiple-loaded anchors). In the case of
an anchor, the first set of anchor sutures is used to create a
mattress stitch and the remaining sutures are passed medial to
lateral in a simple pattern.
An integral feature of the present invention is that the
FiberTape.RTM. rip-stop suture is load-sharing and thereby takes
some of the stress off the fixation sutures of the other anchors.
In prior applications of rip-stop sutures, the rip-stop sutures
have not been load-sharing and, therefore, have been less
protective of poor-quality tissues than the rip-stop sutures of the
present invention.
The present invention provides a unique approach for challenging
rotator cuff repairs that include either poor tendon quality or a
short medial tendon stump using exemplary FiberTape.RTM. suture
tapes and SwiveLock.RTM. anchors for reinforcement. FiberTape.RTM.
is #2 FiberWire.RTM. with a 2 mm wide overbraid that has been shown
to have 30% higher resistance to pulling through tendon than
standard #2 suture and can be used to augment a single row repair
using fixation devices such as Corkscrew.RTM. FT suture anchors.
One or two FiberTape.RTM. sutures are used to create the rip-stop.
The FiberTape.RTM. sutures are secured laterally with knotless
SwiveLock.RTM. anchors in a modified SpeedFix.TM. repair that not
only reinforces the medial stitches, but also shares the load
carried by the simple sutures.
Two preferred embodiments of the technique of the present invention
(single and dual rip-stop) are now described with reference to the
drawings.
FIGS. 1A-1F illustrate schematic views of an anchor-based rip-stop
rotator cuff repair for a rotator cuff tear with lateral tendon
loss (left shoulder, lateral-to-medial view).
FIG. 1A: In this rotator cuff tear with lateral tendon loss, there
is limited space to achieve fixation in the remaining medial tendon
50 (rotator cuff 50).
FIG. 1B: A suture tape (FiberTape.RTM. suture) rip-stop 10 has been
placed as an inverted mattress stitch in the rotator cuff 50.
FIG. 1C: Two medial anchors 20 (for example, BioComposite
Corkscrew.RTM. anchors 20) are placed approximately 5 mm lateral to
the articular margin.
FIG. 1D: The sutures 21, 22 from these anchors 20 are passed medial
to the suture tape rip-stop stitch 10 (arrows).
FIG. 1E: Before sutures 21, 22 from the medial anchors 20 are tied,
the suture tape rip-stop stitch 10 is secured to bone 55 with two
lateral knotless anchors 30 (BioComposite SwiveLock.RTM. C anchors
30).
FIG. 1F: The suture limbs 21, 22 from the medial anchors 20 are
tied to complete the repair.
FIGS. 2E-2F are schematic illustrations of a dual rip-stop rotator
cuff repair.
FIG. 2A: In this medial rotator cuff tear with rotator cuff 50
provided with a lateral tendon stump, there is limited space to
achieve fixation in the medial tendon.
FIG. 2B: Two FiberTape.RTM. rip-stop sutures 10 are placed about 3
mm lateral to the musculotendinous junction as inverted mattress
stitches.
FIG. 2C: Two medial anchors 20 (for example, BioComposite
Corkscrew.RTM. FT anchors 20) are placed in bone 55 (the greater
tuberosity bone bed).
FIG. 2D: Suture limbs 21, 22 from the medial anchors 20
(BioComposite Corkscrew.RTM. anchors 20) are passed medial to the
rip-stop stitches. In addition, the opposite suture limbs 21, 22
are passed through the lateral tendon stump.
FIG. 2E: The FiberTape.RTM. rip-stop sutures 10 are secured
laterally with two knotless anchors 30 (for example, BioComposite
SwiveLock.RTM. C anchors 30). An exemplary SwiveLock.RTM. C anchor
is disclosed and described in U.S. Patent Application Publication
No. 2007/0191849, the disclosure of which is incorporated in its
entirety herewith. These rip-stop sutures are load sharing and are
secured before the Corkscrew anchor sutures 21, 22 are tied. During
this step, it is important to retrieve the rip-stop sutures so that
they surround the lateral sutures limbs from the Corkscrew.RTM.
anchors 20.
FIG. 2F: The repair is completed by tying the sutures limbs 21, 22
from the Corkscrew anchors 20.
The flexible strands/tapes 10, 21, 22 of the present invention may
contain a high strength suture material with surgically-useful
qualities, including knot tie down characteristics and handling,
such as Arthrex FiberWire.RTM. suture disclosed in U.S. Pat. No.
6,716,234, the disclosure of which is incorporated herein by
reference. The sutures/tapes may be provided with optional colored
strands to assist surgeons in distinguishing between suture lengths
with the trace and suture lengths without the trace.
The flexible strands/tapes 10, 21, 22 of the present invention may
be also provided in the form of a suture tape (such as the
FiberTape.RTM. disclosed in U.S. Pat. No. 7,892,256, the disclosure
of which is herein incorporated by reference in its entirety), or a
combination of suture and suture tape.
Preferably, the strands/tapes 10, 21, 22 may be provided as color
contrasting strands to assist surgeons in distinguishing between
them while they are loaded through the eyelet of a suture anchor or
passed through tissue, for example. At least one of the limbs may
be visually coded, making identification and handling of the suture
legs simpler. Multiple strands/tapes 10, 21, 22 may be employed
with the techniques of the present invention.
The single and multiple row constructs of the present invention may
be employed in surgical procedures for repair/reinforcement of soft
tissue, such as rotator cuff repair, Achilles tendon repair,
patellar tendon repair, ACL/PCL reconstruction, hip and shoulder
reconstruction procedures, among many others. The single and double
row constructs may be employed with additional implant material(s)
such as grafts or patches provided arthroscopically (preferably
under the tissue or above the tissue) prior to implanting the
lateral rows of the repair system. The graft or patch may be
allograft or porous collagen material, and may be optionally
hydrated with bone marrow aspirate. The graft or patch may be
placed either above or below the soft tissue (for example, the
rotator cuff) and secured into position at the repair site.
The rip-stop rotator cuff repair techniques described above combine
the advantages of a rip-stop suture (by providing resistance to
tissue cutout) and a double-row repair (by increasing load-sharing
properties). In addition, the techniques use a suture tape that has
shown improved biomechanical properties compared with standard
high-strength sutures. The techniques are particularly useful for
cases in which there is limited medial tendon that precludes a
suture-bridging double-row repair.
While the present invention is described herein with reference to
illustrative embodiments for particular applications, it should be
understood that the invention is not limited thereto. Those having
ordinary skill in the art and access to the teachings provided
herein will recognize additional modifications, applications,
embodiments and substitution of equivalents all fall within the
scope of the invention. Accordingly, the invention is not to be
considered as limited by the foregoing description.
* * * * *